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Trade names | Detectnet |
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Routes of administration | Intravenous |
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Formula | C65H88CuN14O19S2 |
Molar mass | 1497.16 g·mol−1 |
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Copper (64Cu) oxodotreotide or Copper Cu 64 dotatate, sold under the brand name Detectnet, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults. [2]
Common side effects include nausea, vomiting and flushing. [3]
It was approved for medical use in the United States in September 2020. [2] [3]
The U.S. Food and Drug Administration (FDA) approved copper 64Cu dotatate based on data from two trials that evaluated 175 adults. [4]
Trial 1 evaluated adults, some of whom had known or suspected NETs and some of whom were healthy volunteers. [4] The trial was conducted at one site in the United States (Houston, TX). [4] Both groups received copper 64Cu dotatate and underwent PET scan imaging. [4]
Trial 2 data came from the literature-reported trial of 112 adults, all of whom had history of NETs and underwent PET scan imaging with copper 64Cu dotatate. [4] The trial was conducted at one site in Denmark. [4] In both trials, copper 64Cu dotatate images were compared to either biopsy results or other images taken by different techniques to detect the sites of a tumor. [4] The images were read as either positive or negative for presence of NETs by three independent image readers who did not know participant clinical information. [4]